An 8 Week Study to Evaluate Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder - Full Text View

Sponsor:	Cephalon
Information provided by:	Cephalon
ClinicalTrials.gov Identifier:	NCT00481195

Purpose

The primary objective of the study is to determine if armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with Bipolar I Disorder and who are inadequately responsive to their current treatment for a current major depressive episode.

Condition	Intervention	Phase
Bipolar I Depression	Drug: Armodafinil	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An 8 Week Double Blind, Placebo-Controlled, Parallel Group, Fixed Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Armodafinil

U.S. FDA Resources

Further study details as provided by Cephalon:

Primary Outcome Measures:

Determine if armodafinil treatment is more effective than placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with Bipolar I Disorder, as assessed by the IDS-C30. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

MADRS, QIDS-SR16, Q-LES-Q-SF, HAM-A, CGI-BP [ Time Frame: 8 weeks, and at Intermediate Points ] [ Designated as safety issue: No ]
YMRS [ Time Frame: 8 weeks, and at Intermediate Points ] [ Designated as safety issue: Yes ]

Enrollment:	264
Study Start Date:	May 2007
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Armodafinil Patients will begin oral treatment with armodafinil or placebo, which will be titrated to 150 mg/day (3 tablets) of the randomly assigned study drug (armodafinil or placebo).

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

The patient has a diagnosis of Bipolar I Disorder and is currently experiencing a major depressive episode.
The patient is currently being treated with 1 or 2 of the following drugs: lithium, olanzapine, or valproic acid.

Key Exclusion Criteria:

The patient has any Axis I disorder apart from Bipolar I Disorder that was the primary focus of treatment within 6 months before the screening visit (with the exception of nicotine dependence).
The patient has any clinically significant uncontrolled medical or surgical condition.
The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.
The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481195

Show 55 Study Locations

Sponsors and Collaborators

Cephalon

More Information

No publications provided

Responsible Party:	Cephalon ( Sponsor's Medical Expert )
Study ID Numbers:	C10953/2032/DP/US
Study First Received:	May 30, 2007
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00481195 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Depression
Physiological Effects of Drugs
Central Nervous System Stimulants
Depressive Disorder, Major
Depressive Disorder
Protective Agents
Neuroprotective Agents

Modafinil
Pharmacologic Actions
Behavioral Symptoms
Mental Disorders
Therapeutic Uses
Mood Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 05, 2009